Members of the House of Representatives propose fast-track legalization to change rules for cannabis research
On July 26, lawmakers approved the bipartisan Medical Cannabis and Cannabidiol Research Expansion Act to streamline the application process for researchers and remove FDA hurdles.
Members of the United States House of Representatives last night voted in favor of a law called " The Medical Marijuana and Cannabidiol Research Expansion Act“, which aims to facilitate scientific research on cannabis and potential drug development.
Two hundred and sixteen Democrats voted in favor of the bill, along with 109 Republicans. Ninety-five Republicans voted against moving the bill forward.
It now moves to the Senate, where lawmakers had already voted unanimously in favor of similar legislation in April. It is expected that the bill will be quickly forwarded to the President's office.
The law gives the US Attorney General's office 60 days to approve or deny applications from scientists to engage in clinical trials involving the use of cannabis by human subjects. (Protocols must first be reviewed and approved by the Secretary of the U.S. Department of Health and Human Services and the National Institutes of Health before being authorized by the Attorney General. These agencies do not have a explicit deadline for completing their reviews).
The law also directs the United States Attorney General to solicit applications from those wishing to cultivate cannabis for the purposes of research or potential drug development, and provides a time frame within which the Attorney General must approve such applications. .
The law also requires federal agencies, including HHS, to provide a report on the “potential therapeutic effects of cannabidiol or marijuana on serious medical conditions.” In the past, the US National Academy of Sciences, Engineering, and Medicine has compiled similar reports of this nature for Congress, although these reports have received little attention.
Under current regulations, the US Drug Enforcement Administration is primarily responsible for reviewing and issuing licenses to marijuana growers, as well as granting Schedule I licenses to scientists wishing to study cannabis within a framework. clinical. In 2016, the agency announced that it would expand the pool of federally licensed growers beyond just the University of Mississippi (which originally obtained a federal license to grow cannabis in 1968). In May 2021, the agency announced that it had reached agreements with a handful of third-party applicants to allow them to cultivate cannabis for use in federally approved clinical trials. However, the US National Institute on Drug Abuse has yet to formally partner with any of these entities and there is no explicit timeline as to when it will.
For decades, scientists who want to work on marijuana have complained that it often takes years for their research protocols to be approved by the DEA, and the quality of cannabis provided by the marijuana cultivation program. University of Mississippi is substandard and not representative of products available in legal state markets.
In response to these complaints, members of the House of Representatives earlier this year passed HR 5657: The Medical Marijuana Research Act, which allows licensed scientists access to cannabis flowers for the first time. and other products manufactured under state-approved marijuana cultivation programs. However, these explicit provisions were not included in the new bill which is being fast-tracked by both houses.
The deputy director of NORML, Paul Armentano, criticized this omission. "Currently, the limited variety of cannabis cultivars available to federally licensed researchers do not represent the type or quality of cannabis products currently available in legal state markets," he said. "The fact that nearly half of American adults have legal access to this multitude of cannabis products, but our nation's top scientists do not, is the height of absurdity and an indictment of the current system. This proposal misses the opportunity to change this reality”.
Separate legislation in the House of Representatives — the new Developing and Nationalizing Key Cannabis Research Act of 2022, sponsored by Congressmen Scott Peters (D-CA) and David Joyce (R-OH) — allows scientists licensed to perform clinical testing of state-licensed cannabis products and allocates funds for the establishment of academic research centers to engage in “interdisciplinary cannabis-related research.”
Despite federal hurdles, scientific interest and studies involving cannabis have increased dramatically over the past two decades. Since 2010, scientists in the United States and around the world have published approximately 30 peer-reviewed articles referring to the cannabis plant or its constituents, with the total number of articles increasing each year. By comparison, researchers published less than 000 total papers on marijuana between 3 and 000 and less than 1990 total studies during the 1999s.